This service pack introduces several key enhancements to the Quality Event (QE) application, designed to improve how quality events are reported, investigated, and managed.
Key Enhancements:
- Reported By and Reported Date Fields
To improve tracking and accuracy, two new fields—Reported By and Reported Date—have been added to the New Quality Event form. These fields are defined as follows:
- Reported By: Identifies the individual who reported the event.
- Reported Date: Specifies the date the event was reported.
As shown in the screenshot below, the Reported By and Reported Date fields are automatically populated with the logged-in user’s name and the current date, similar to the Created By and Creation Date fields. However, unlike those fields, the new fields are editable, allowing for updates if the actual reporter or reporting date differs from the default values.
- New Event Types
The New Quality Event form now offers three additional options in the Event Type dropdown: Hazard (H&S), Issue, and Near-Miss. These additions enable more precise classification, improving reporting accuracy and ensuring a more targeted response.
| Event Type | Definition | Updated Quality Event ID Format |
|---|---|---|
| Hazard (H&S) | A potential source of harm or adverse effects on people, property, or the environment, arising from conditions, activities, or materials. Hazards must be identified proactively to reduce risks and ensure compliance with safety standards. | QE-HS-XXXXX |
| Issue | A problem or obstacle that has already occurred and is currently affecting the project, process, or operations. Issues require immediate attention and resolution to prevent further impact. | QE-ISS-XXXXX |
| Near-Miss | An event that could have resulted in an accident, injury, or damage but was narrowly avoided, either by chance or through timely intervention. Reporting near misses helps identify potential hazards and enhances safety measures to prevent future incidents. | QE-NM-XXXXX |
- Tooltip for Issue Statement Field
A new tooltip has been added to the Provide a Detailed Statement of the Issue field in the New Quality Event form, offering guidance on what to include, such as immediate actions taken and key individuals involved. This ensures users provide complete and useful event descriptions, ensuring that anyone reviewing the event has the context needed to act effectively.
- Incident Details Accordion
When an incident is escalated to a quality event or CAPA, the workflow forms now include an Incident Details section, displayed as an accordion. This section provides key information from the linked incident, including:
- Incident ID
- Name
- Severity
- Date of Incident
- Incident Reviewer
- Editable Review Notes at Gather Details Stage
The Review Notes field is now editable at the Gather Details stage of the QE Management workflow, allowing users to add detailed notes or insights before the quality event advances to the CAPA assessment stage.
- Investigation Type Dropdown
A new Investigation Type dropdown has been added to the Gather Details (Root Cause Analysis) accordion in the Gather Details form. This dropdown allows users to select an investigation approach based on the complexity or severity of the quality event, ensuring the analysis depth aligns with the situation.
Dropdown Options:
- None: No investigation type selected.
- Simple: Basic investigation approach for minor or less complex issues.
- Advanced: Detailed investigation approach for major or critical issues.
When Simple or Advanced is selected, an Investigation Technique field will appear, allowing users to specify the method or technique being used.
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